Product class:
|
Authorized package
|
Medicinal product class:
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For human use
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Package code:
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1305818
|
Name of medicinal product:
|
AMMILY 2 MG / 0,03 MG
|
Active substances:
|
|
ATC code:
|
G03AA16
|
Dosage form:
|
film-coated tablet
|
Route of administration:
|
oral use
|
Strengh:
|
2mg+0,03mg
|
Amount in package:
|
21TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
- Oral contraception.
- Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
The decision to prescribe [invented name] should take into consideration the individual womans current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated April 12, 2023)
|
Package information leaflet (PIL):
|
EST (last updated April 12, 2023)
|
Labelling:
|
(last updated November 3, 2021)
|
Last imported to Estonia:
|
May 26, 2023
|
Marketing authorization holder:
|
Orivas UAB
|
Marketing authorization number:
|
617409
|
Marketing authorization issued on:
|
February 6, 2009
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
90
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
4 years - 17 years
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
100
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
until 4 years
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
100
|
01.04.2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
75
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
90
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
50
|
01.04.2023
|
|
Yes
|
|
|
No
|
|
|
90
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
from 63 years
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
90
|
01.04.2023
|
|
Yes
|
Z30-Z30
|
|
No
|
|
sünnitamisele meditsiinilise vastunäidustuse korral
|
Reference price:
|
5,67 EUR
|
Under reference price:
|
Yes
|
Reference price of daily dose:
|
0,27 EUR
|
Description
|
Additional condition
|
Ämmaemandal on õigus välja kirjutada
|
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
April 12, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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